Device product
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Z-2909-2016
Product summary
- Event
- Event 75065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-2909-2016
Official wording
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information: Catalog Number 951303, Lot #0195786 with expiry 05/2019
Distribution pattern: Nationwide Distribution to KS only
Derived failure modes
-
Labeling or packaging
incomplete packaging